Senior Manager Supplier Quality – Surgical Workflow-Infection Control Consumables (SWICC)

Job title: Senior Manager Supplier Quality – Surgical Workflow-Infection Control Consumables (SWICC)

About the Role The Senior Manager Supplier Quality for Surgical Workflow-Infection Control Consumables (SWICC) leads and executes the supplier quality management program across multiple sites, serving as the key quality contact between suppliers and internal teams to ensure supplier qualification, auditing, and accountability. This role also leads a team of Supplier Quality Engineers and collaborates with Procurement, Operations, and R&D to mitigate supply chain quality risk and drive continuous improvement.

What You'll Do

• Establish a world-class supplier management program within the SWICC Business Segment.
• Qualify, approve, and re-evaluate vendors and service providers per the SWICC supplier management program, in compliance with ISO 13485:2016 and other applicable regulations (e.g., EU MDR).
• Develop and maintain a risk-based supplier qualification process, including quality questionnaires, desktop assessments, and on-site capability evaluations; maintain the SWICC Approved Supplier List (ASL) and all vendor management files.
• Plan and conduct scheduled vendor audits to assess compliance with FDA, ISO 13485:2016, internal QMS requirements, and applicable regulatory standards; manage audit scheduling, observation documentation, findings reporting, and verification of corrective action effectiveness.
• Plan and conduct For-Cause audits to address critical vendor management concerns resulting from changes in vendors' processes, previous audit findings, recurring non-conformances, suspected vendor-related issues, or escalated risk events.
• Participate as a member of the internal audit team, applying auditing principles and procedures to routine and for-cause assessments of cGMP/QMS compliance within the SWICC quality system.
• Ensure Supplier Quality oversight regarding the disposition of supplier-caused non-conformances; coordinate with Operations and site QRC teams on quarantine, rework, return, and replacement activities; address systemic non-conformance patterns through corrective action.
• Issue, manage, and close Supplier Corrective Action Requests (SCARs); facilitate root cause analysis with suppliers, verify effectiveness of corrective actions, and escalate non-responsive suppliers as required; maintain program-level SCAR metrics and drive accountability at the supplier executive level when necessary.
• Develop and maintain supplier scorecards and performance dashboards covering quality, delivery, and responsiveness KPIs; prepare and present supplier performance trends at QRC and Management Review forums; translate performance data into strategic sourcing and supplier development recommendations for leadership.
• Develop supplier improvement plans for underperforming or strategically critical suppliers to mitigate risk to SWICC operations.
• Review, negotiate, and maintain Quality Agreements (QAs) with vendors providing materials, components, and services that impact cGMP operations; ensure agreements are executed, enforceable, and periodically reviewed.
• Represent Supplier Quality in New Product Introduction (NPI) and product transfer projects; ensure supplier approval and quality system readiness are in place prior to commercial launch. Product quality requirements and specifications remain the responsibility of R&D.
• Review and communicate supplier-initiated requests for engineering changes or material substitutions; evaluate for quality system impact and route to R&D and Operations for technical disposition.
• Collaborate with Procurement to ensure supplier performance data informs sourcing decisions, contract renewals, and re-qualification triggers.
• Facilitate changes to supplier status (e.g., approval, restriction, disqualification) and ensure all required documentation and activities are completed.
• Author, review, and revise Supplier Quality procedures, work instructions, and associated records/documentation within the SWICC QMS; complete trending and analysis of supplier defects, recurring problems, and corrective actions; present program-level trend summaries to QRC leadership and functional stakeholders on a recurring basis.
• Actively participate with Procurement, Operations, and R&D to continuously improve supplier evaluation, risk assessment, and mitigation processes across the SWICC segment.
• Travel to supplier locations to conduct audits, facilitate resolution of quality problems, and support qualification activities as required.
• Lead, coach, and develop a team of Supplier Quality Engineers (SQEs) across SWICC sites; set performance expectations, support professional development, manage workload prioritization, and foster a culture of quality and accountability.

What We're Looking For

• Extensive experience in supplier quality management within medical devices or life sciences, including leadership of multi-site SQE teams.
• Strong auditing experience (vendor, internal, For-Cause) against FDA QMS and ISO 13485:2016 requirements; experience with cGMP/QMS compliance.
• Demonstrated ability to develop risk-based supplier qualification programs, supplier scorecards, SCARs, CAPA, and corrective actions with proven effectiveness.
• Proficiency in Quality Agreements, NPI/product transfer support, and qualification activities prior to commercial launch.
• Excellent cross-functional collaboration skills with Procurement, Operations, and R&D; ability to translate supplier performance data into strategic actions.
• Strong analytical and data visualization capabilities; able to present trends and metrics at leadership/Management Review forums.
• Travel willingness to supplier locations as required by audits and qualification activities.
• Bachelor's degree in a science/engineering field or equivalent experience; strong communication and leadership capabilities.